Metastatic Lung AdenocarcinomasNTSNCT02891733
Retrospective Analysis of the Expression of the Neurotensin Receptor by Metastatic Lung Adenocarcinomas
An observational study of Metastatic Lung Adenocarcinomas, run by Fondation Hôpital Saint-Joseph.
Trial summary
Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of patients present themselves with a disease diagnosis immediately metastatic non curable. Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based chemotherapy with or without maintenance therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Lung Adenocarcinomas
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients consecutively treated between 2010 and 2015 at St. Joseph hospital (about a hundred patients) and the Saint-Antoine hospital (three hundred patients), holders of a primary lung adenocarcinoma in the metastatic setting and having all received the same first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
Who may be able to join
- Patients with adenocarcinoma in metastatic stage
- Patients received
- The same first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
Who cannot join
- No exclusion criteria
About this study
Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of patients present themselves with a disease diagnosis immediately metastatic non curable. Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based chemotherapy with or without maintenance therapy. When there is to exhaust this first line, a second line treatment is offered to the patient. Three drugs are allowed in this situation: docetaxel, erlotinib (inhibitor of the tyrosine kinase activity of the receptor for epidermal growth factor - TKI-EGFR) and pemetrexed (which in fact has become virtually standard in first online and in combination with platinum in all patients with non-squamous cancer, so that his place is in second line reduced facto). There is no recommendation for treatment in third line situation where only erlotinib is allowed.
Most recently, the nivolumab, anti-PD1 monoclonal antibody (which aims to enable immunutaire system) saw its demonstrated effectiveness in the second line and beyond in the two Phase 3 trials where it was compared with docetaxel for the treatment of squamous cell carcinoma and non-squamous. The very recent availability in France of the drug under an ATU fact that it will most likely become a standard second line, which will tend to place the third line docetaxel.
Read more
Therefore, erlotinib will be in 4th line situation. However, in the absence of an EGFR mutation (which is only seen in more than 10% of Caucasian patients) use of the drug does not seem appropriate or even harmful. A selection of patients likely to benefit from the prescription of EGFR TKI-is essential.
Neurotensin (NTS) is a polypeptide of 13 amino acids present and active in the central nervous system and the periphery. At the peripheral level, neurotensin is secreted postprandial by endocrine cells in the intestinal mucosa and is involved in the motor functions of the gastrointestinal tract. The effects of neurotensin pass through the activation of three subtypes of receptors which, mainly, NTSR1 and NTSR2 which are receptors coupled to G proteins in the extra-digestive normal tissues, including lung, torque NTS / NTSR1 n is not expressed physiologically. Rather, this complex is likely to recur in tumor tissues.
The mechanism of this effect is derogatory activation torque NTS / NTSR1 of matrix metalloproteinases which causes the release by the cell membrane ligands "EGF-like" and thus, activation of HER receptor (EGFR or HER1, HER2 and HER3). Indeed, in experimental tumors created by subcutaneous injection in athymic mouse cell lines adenocarcinomas NTS + / NTSR1 + (non-mutated EGFR), treatment with erlotinib - which blocks EGFR pathway - causes a significant decrease of tumor growth.
Expression of the neurotensin receptor in cancer cells metastatic primary bronchial adenocarcinoma is not known. Therefore, its pejorative prognostic value is not confirmed in the metastatic setting.
Read the detailed description
The objectives of this work purely descriptive, are:
- Evaluate the expression by tumor cells of the neurotensin receptor on a retrospective series of patients:
- Consecutively treated between 2010 and 2015 at St. Joseph hospital (about a hundred patients) and the Saint-Antoine hospital (three hundred patients), holders of a metastatic and primary lung adenocarcinoma having received all even first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
- If possible, the records of patients treated at St. Joseph Hospital and Saint-Antoine Hospital between 2005 and 2010 as part of clinical trials evaluating the value of erlotinib will also be sought,
- Develop a score expression NTSR1 taking into account the percentage of tumor cells expressing the receptor and the intensity of the marking,
- Correlate labeling cells by NTSR1 with the clinical course of patients to see if expression NTSR1 is a factor of poor prognosis in metastatic patients.
Teams involved:
Services:
- Pharmacy that will establish the list of patients have been treated with the same chemotherapy,
- Pathological anatomy-to group blades and ensure immunohistochemical staining and reading,
- Pneumology and Thoracic Oncology to resume the clinical history of patients.
The scientific coordination of the study will be conducted by INSERM UMR-S 1007, cellular homeostasis and cancer - Reprogramming of biological and alternative therapies responses (University Center of the Holy Fathers, 45 rue des Saints Pères, 75006 Paris), one team under the direction of Dr. Patricia Forge, working on the couple NTS / NTSR1.
expected benefits
Beyond two or three conventional chemotherapy line, which will no doubt add - for a proportion of patients still to be determined - the new immunotherapy drugs, there is no longer any recommendations for treatment of patients lung cancer metastatic non-small cells. Erlotinib is an option since there is no limitation in its approval of prescription ond line. However, in the absence of EGFR mutation, the therapeutic value of the drug appears to be very low. Preclinical data that investigators obtained in the laboratory are hypothesize that tumors expressing NTSR1 could meet the same TKI EGFR in the absence of mutation in the receptor. The planned study will assess the percentage of patients in this situation in order to prepare the organization of a Phase II study to evaluate the clinical relevance of a TKI EGFR in this selected population of patients carrying of a non-mutated tumor.
Nature of the data collected
A file will be drawn from the clinical data found in files: all patients are carriers of metastatic primary lung adenocarcinoma and having all received the same chemotherapy.
The data obtained will be: age, sex, smoking status, number of courses of chemotherapy received and the response to treatment, the usual chronological parameters for the establishment of the survival curves. Histological samples will be processed locally in each of the two hospitals, according to a specific procedure to be determined between laboratories and INSERM Unit.
Identification of subjects and circulation and processing of data
In this study, the inclusions are carried out within the hospital group Paris Saint-Joseph and Saint-Antoine hospital. Histological samples will be processed locally in each of the two hospitals, according to a specific procedure to be determined between pathological anatomy and INSERM Unit Laboratories.
These histological samples will be stored at the Pathological Anatomy Laboratory Groupe Hospitalier Paris Sani Joseph.
Each study participant will be identified by a code of inclusion (first name and surname - year of birth). The concordance table to link the assigned code and the participant's name will be kept in each of the participating centers, in a file protected by a password specific to the principal investigator of each center. Data collected from different centers on anonymous paper media (only the code for inclusion of each patient are included) will be centralized within the GHPSJ and entered in a database which anonymous access is protected by the PIN each in the study of GHPSJ. Data processing and statistical analysis will be performed on the GHPSJ site in collaboration with the Clinical Research Unit of the European Hospital Georges Pompidou.
- Conditions
- Metastatic Lung Adenocarcinomas
- Keywords
- Expression of the Neurotensin, Neurotensin
- Medical subject headings
- Adenocarcinoma of Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient expressing Neurotensin receptor ( NTSR1) in their tumor
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start6 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: The principal investigator decided to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lung AdenocarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891733
- Sponsor's protocol ID
- NTS
- Acronym
- NTS
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2016
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Expression of the Neurotensin Receptor by Metastatic Lung Adenocarcinomas
- ClinicalTrials.gov ID
- NCT02891733
- Acronym / sponsor ID
- NTS / NTS
- Conditions
- Metastatic Lung Adenocarcinomas
- Keywords
- Expression of the Neurotensin, Neurotensin
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The principal investigator decided to stop the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of cancer mortality in France and worldwide. 60% of patients present themselves with a disease diagnosis immediately metastatic non curable. Adenocarcinomas account for 50% of incident tumors. Treatment is based on the platinum-based chemotherapy with or without maintenance therapy. When there is to exhaust this first line, a second line treatment is offered to the patient. Three drugs are allowed in this situation: docetaxel, erlotinib (inhibitor of the tyrosine kinase activity of the receptor for epidermal growth factor - TKI-EGFR) and pemetrexed (which in fact has become virtually standard in first online and in combination with platinum in all patients with non-squamous cancer, so that his place is in second line reduced facto). There is no recommendation for treatment in third line situation where only erlotinib is allowed.
Most recently, the nivolumab, anti-PD1 monoclonal antibody (which aims to enable immunutaire system) saw its demonstrated effectiveness in the second line and beyond in the two Phase 3 trials where it was compared with docetaxel for the treatment of squamous cell carcinoma and non-squamous. The very recent availability in France of the drug under an ATU fact that it will most likely become a standard second line, which will tend to place the third line docetaxel.
Therefore, erlotinib will be in 4th line situation. However, in the absence of an EGFR mutation (which is only seen in more than 10% of Caucasian patients) use of the drug does not seem appropriate or even harmful. A selection of patients likely to benefit from the prescription of EGFR TKI-is essential.
Neurotensin (NTS) is a polypeptide of 13 amino acids present and active in the central nervous system and the periphery. At the peripheral level, neurotensin is secreted postprandial by endocrine cells in the intestinal mucosa and is involved in the motor functions of the gastrointestinal tract. The effects of neurotensin pass through the activation of three subtypes of receptors which, mainly, NTSR1 and NTSR2 which are receptors coupled to G proteins in the extra-digestive normal tissues, including lung, torque NTS / NTSR1 n is not expressed physiologically. Rather, this complex is likely to recur in tumor tissues.
The mechanism of this effect is derogatory activation torque NTS / NTSR1 of matrix metalloproteinases which causes the release by the cell membrane ligands "EGF-like" and thus, activation of HER receptor (EGFR or HER1, HER2 and HER3). Indeed, in experimental tumors created by subcutaneous injection in athymic mouse cell lines adenocarcinomas NTS + / NTSR1 + (non-mutated EGFR), treatment with erlotinib - which blocks EGFR pathway - causes a significant decrease of tumor growth.
Expression of the neurotensin receptor in cancer cells metastatic primary bronchial adenocarcinoma is not known. Therefore, its pejorative prognostic value is not confirmed in the metastatic setting.
Detailed description
The objectives of this work purely descriptive, are:
- Evaluate the expression by tumor cells of the neurotensin receptor on a retrospective series of patients:
- Consecutively treated between 2010 and 2015 at St. Joseph hospital (about a hundred patients) and the Saint-Antoine hospital (three hundred patients), holders of a metastatic and primary lung adenocarcinoma having received all even first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
- If possible, the records of patients treated at St. Joseph Hospital and Saint-Antoine Hospital between 2005 and 2010 as part of clinical trials evaluating the value of erlotinib will also be sought,
- Develop a score expression NTSR1 taking into account the percentage of tumor cells expressing the receptor and the intensity of the marking,
- Correlate labeling cells by NTSR1 with the clinical course of patients to see if expression NTSR1 is a factor of poor prognosis in metastatic patients.
Teams involved:
Services:
- Pharmacy that will establish the list of patients have been treated with the same chemotherapy,
- Pathological anatomy-to group blades and ensure immunohistochemical staining and reading,
- Pneumology and Thoracic Oncology to resume the clinical history of patients.
The scientific coordination of the study will be conducted by INSERM UMR-S 1007, cellular homeostasis and cancer - Reprogramming of biological and alternative therapies responses (University Center of the Holy Fathers, 45 rue des Saints Pères, 75006 Paris), one team under the direction of Dr. Patricia Forge, working on the couple NTS / NTSR1.
expected benefits
Beyond two or three conventional chemotherapy line, which will no doubt add - for a proportion of patients still to be determined - the new immunotherapy drugs, there is no longer any recommendations for treatment of patients lung cancer metastatic non-small cells. Erlotinib is an option since there is no limitation in its approval of prescription ond line. However, in the absence of EGFR mutation, the therapeutic value of the drug appears to be very low. Preclinical data that investigators obtained in the laboratory are hypothesize that tumors expressing NTSR1 could meet the same TKI EGFR in the absence of mutation in the receptor. The planned study will assess the percentage of patients in this situation in order to prepare the organization of a Phase II study to evaluate the clinical relevance of a TKI EGFR in this selected population of patients carrying of a non-mutated tumor.
Nature of the data collected
A file will be drawn from the clinical data found in files: all patients are carriers of metastatic primary lung adenocarcinoma and having all received the same chemotherapy.
The data obtained will be: age, sex, smoking status, number of courses of chemotherapy received and the response to treatment, the usual chronological parameters for the establishment of the survival curves. Histological samples will be processed locally in each of the two hospitals, according to a specific procedure to be determined between laboratories and INSERM Unit.
Identification of subjects and circulation and processing of data
In this study, the inclusions are carried out within the hospital group Paris Saint-Joseph and Saint-Antoine hospital. Histological samples will be processed locally in each of the two hospitals, according to a specific procedure to be determined between pathological anatomy and INSERM Unit Laboratories.
These histological samples will be stored at the Pathological Anatomy Laboratory Groupe Hospitalier Paris Sani Joseph.
Each study participant will be identified by a code of inclusion (first name and surname - year of birth). The concordance table to link the assigned code and the participant's name will be kept in each of the participating centers, in a file protected by a password specific to the principal investigator of each center. Data collected from different centers on anonymous paper media (only the code for inclusion of each patient are included) will be centralized within the GHPSJ and entered in a database which anonymous access is protected by the PIN each in the study of GHPSJ. Data processing and statistical analysis will be performed on the GHPSJ site in collaboration with the Clinical Research Unit of the European Hospital Georges Pompidou.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients consecutively treated between 2010 and 2015 at St. Joseph hospital (about a hundred patients) and the Saint-Antoine hospital (three hundred patients), holders of a primary lung adenocarcinoma in the metastatic setting and having all received the same first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
Key inclusion criteria (3 listed)
- Patients with adenocarcinoma in metastatic stage
- Patients received
- The same first-line chemotherapy with a platinum agent (cisplatin or carboplatin) and pemetrexed (Alimta °)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient expressing Neurotensin receptor ( NTSR1) in their tumor
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Lung Adenocarcinomas, run by Fondation Hôpital Saint-Joseph.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient expressing Neurotensin receptor ( NTSR1) in their tumor (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.